StratCare Trial 2: Evaluating the Clinical and Cost-effectiveness of AI-driven Stratified Care for Depression

NCT06567340 | Not Yet Recruiting DMC

• 3 other identifiers: 152958329457153364
• Study Type: interventional
• Target: 1,252
• Locations: 1 country
• Sites: 1

Brief Summary

Depression and anxiety are common mental health problems affecting around one in six adults. Treatments include therapy, telephone or group-based activities delivered by therapists. Treatment uses a "stepped care" model where most patients start with very brief treatments. If they remain unwell after this, they access longer and more intensive therapy. This model does not always work, as only one out of two patients fully recover. The researchers have developed an artificial intelligence tool called "StratCare". It is designed to help health services to offer the best available treatment for each patient. StratCare is a computerised system that guides therapists on how to assess new patients. It asks a few questions about their symptoms, personality, and background. The system makes a recommendation about which treatment might be most effective for that person. This is either starting with brief therapy or starting with intensive therapy. The treatments are already used with depression in the National health Service (NHS). The patient can discuss with their therapist and decide whether to accept the recommendation. Otherwise, they can discuss trying other options. Previous research found that StratCare can help more people to recover from depression compared to the usual stepped care model. The researchers will investigate if the StratCare tool works on a large scale in the NHS and if it helps patients in the long-term. The researchers will run a trial involving 1252 participants using NHS Talking Therapies services. Half will use the StratCare tool to make a treatment recommendation. The other half will follow the stepped care approach. The researchers will contact participants in the trial after 6, 12 and 18 months to see if their mood and quality of life has improved. The researchers will also interview therapists and participants to see what they think about treatment being guided by the StratCare tool. Hypotheses:

• Stratified care will result in lower mean depression scores compared to usual stepped care (USC).
• Stratified care will result in a statistically significant higher proportion of cases with reliable and clinically significant improvement in depression symptoms, compared to USC. Primary Outcome: Depressive symptoms, as measured by change on the Patient Health Questionnaire (PHQ-9), at 12 months post-enrolment.

Conditions

Depression

Keywords

Software; Medical Devices; Mental Health; Anxiety; Psychotherapy; Cognitive Behavioural Therapy; Mood Disorders; Mental Health Services

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms from enrolment, as measured by the Patient Health Questionnaire (PHQ-9)

  The PHQ-9 is a brief measure of depression symptoms, where each of 9 items is rated on a Likert scale from 0 to 3 representing symptom frequency in the last two weeks, yielding an overall severity score between 0 and 27. The cut-off ≥10 is recommended to screen for clinically significant depression symptoms, and a change of ≥6 points is indicative of statistically reliable change. The PHQ-9 has been extensively validated in primary care populations, with adequate sensitivity (88%) and specificity (88%) estimates for the detection of major depressive disorder using a cut-off score ≥10.

  12 months post-enrolment.

Secondary Outcomes (5)

• Change in anxiety symptoms from enrolment, as measured by the Generalised Anxiety Disorder Questionnaire (GAD-7)

  6, 12 and 18 months post-enrolment.

• Change in Quality of Life (to derive Quality Adjusted Life Years) from enrolment, as measured by the EQ-5D-5L

  6, 12 and 18 months post-enrolment.

• Change in Quality of Life from enrolment, as measured by the Recovering Quality of Life Scale 10 item version (ReQoL-10)

  6, 12 and 18 months post-enrolment.

• Resource use across the trial duration, measured using an adapted Adult Service Use Schedule (AD-SUS)

  6, 12 and 18 months post-enrolment.

• Change in depressive symptoms from enrolment, as measured by the Patient Health Questionnaire (PHQ-9)

  6 and 18-months post enrolment.

Study Arms (2)

StratCare

EXPERIMENTAL

Treatment recommendation made by the StratCare-2 App using stratified care principles.

Device: StratCare

Usual Stepped Care

NO INTERVENTION

Treatment recommendation made using usual stepped care principles.

Interventions

StratCare DEVICE

The StratCare app is a technology that collects data, processes inputs using a machine learning algorithm, and outputs a personalised treatment recommendation using automated decision rules. The inputs for the algorithm include patient-reported measures of depression, anxiety, functional impairment, personality traits, employment status and ethnic background. The algorithm calculates an expected prognosis (i.e., a probability of full remission of depression and anxiety symptoms after treatment), based on which patients are classified as standard (better expected prognosis) or complex cases. Standard cases are matched to low-intensity treatments and later have the option to move to high-intensity, whereas complex cases are matched directly to high-intensity treatments. In addition, the StratCare app is programmed to implement decision rules that ensure compliance with national clinical guidelines for the treatment allocation of patients with specific disorders.

StratCare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Patients who consent to share their de-identified clinical records for research purposes.
• Patients assessed as eligible for psychological care in Talking Therapies based on clinical guidelines.
• Patients with case-level depression symptoms (PHQ-9 ≥ 10).

You may not qualify if:

• Those who are ineligible for treatment in Talking Therapies services according to standard treatment guidelines.

Sponsors & Collaborators

• Rotherham Doncaster and South Humber NHS Foundation Trust: lead
• University of Sheffield: collaborator
• FSA Research Consulting Inc: collaborator

Study Sites (1)

Rotherham Doncaster and South Humber NHS Foundation Trust

Doncaster, South Yorkshire, DN4 8QN, United Kingdom

Location

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Related Links

• National Institute of Health Research (NIHR) Research Funding Award StratCare-2

MeSH Terms

Conditions

Depression; Psychological Well-Being; Anxiety Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction; Mental Disorders

Study Officials

• Jaime Delgadillo, Prof

  University of Sheffield

  PRINCIPAL INVESTIGATOR

• Michael Barkham, Prof

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Woodward

CONTACT

0114 2222966; ben.thompson@sheffield.ac.uk

Jeannie McKie

CONTACT

03000 212456; rdash.research-gov@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Trial statisticians will be blinded to allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A pragmatic, single-blind, multi-site, parallel group cluster RCT. Cluster randomisation will be used to allocate Talking Therapies Teams and their patients to either intervention or usual care arms. In the experimental arm, treatment selection will be guided by an AI tool (StratCare app). In the USC arm, treatment will be selected following usual clinical practice and guidelines.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: July 7, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)